Trials
HPS-4/TIMI 65 ORION-4
Trial HPS-4/TIMI 65 ORION-4: Cardiovascular outcomes study Aim To assess the effect of inclisiran on major cardiovascular events Study design Randomised, double-blind, placebo-controlled. Patients will be randomised to treatment with inclisiran sodium 300 mg or matching placebo for a median of about 5 years. Treatment…
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ORION-5
Trial A Study of Inclisiran in Participants With Homozygous Familial Hypercholesterolemia (HoFH) (ORION-5) ClinicalTrials.gov Identifier: NCT03851705 Aim To evaluate the safety, tolerability, and efficacy of inclisiran in subjects with homozygous familial hypercholesterolemia (HoFH) Study Design Multicentre Phase III study conducted in two parts; double-blind placebo-controlled…
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ORION-7
Trial A Study of Inclisiran in Participants With Renal Impairment Compared to Participants With Normal Renal Function ClinicalTrials.gov Identifier: NCT03159416 Aim To evaluate the safety, tolerability, pharmacokinetics (PK), and pharmacodynamics of a single dose of inclisiran subcutaneous (SC) injection in participants with mild, moderate, and…
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ORION-8
Trial Trial to Assess the Effect of Long Term Dosing of Inclisiran in Subjects With High CV Risk and Elevated LDL-C (ORION-8) ClinicalTrials.gov Identifier: NCT03814187 Aim To evaluate the efficacy, safety, and tolerability of long-term dosing of inclisiran. Study Design Global multicentre, open label, long…
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ORION-9
Trial Trial to Evaluate the Effect of Inclisiran Treatment on Low Density Lipoprotein Cholesterol (LDL-C) in Subjects With Heterozygous Familial Hypercholesterolemia (HeFH) (ORION-9) ClinicalTrials.gov Identifier: NCT03397121 Aim To evaluate the efficacy, safety, and tolerability of subcutaneous (SC) injection(s) of inclisiran in patients with heterozygous familial…
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ORION-10
Trial Inclisiran for Participants With Atherosclerotic Cardiovascular Disease and Elevated Low-density Lipoprotein Cholesterol (ORION-10) ClinicalTrials.gov Identifier: NCT03399370 Aim To Evaluate the Effect of 300 mg of Inclisiran Sodium Given as Subcutaneous Injections in Subjects With Atherosclerotic Cardiovascular Disease (ASCVD) and Elevated LDL-C Study Design Phase…
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ORION-11
Trial Inclisiran for Subjects With Atherosclerotic Cardiovascular Disease and Elevated Low-density Lipoprotein Cholesterol (ORION-11) ClinicalTrials.gov Identifier: NCT03400800 Aim To Evaluate the Effect of 300 mg of Inclisiran Sodium Given as Subcutaneous Injections in Subjects With Atherosclerotic Cardiovascular Disease (ASCVD) and Elevated Low-Density Lipoprotein Cholesterol (LDL-C)…
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ORION-13
Trial Study to Evaluate Efficacy and Safety of Inclisiran in Adolescents With Homozygous Familial Hypercholesterolemia (ORION-13). ClinicalTrials.gov Identifier: NCT04659863 Aim To investigate the efficacy, safety, and tolerability of inclisiran in adolescents diagnosed with homozygous familial hypercholesterolaemia (HoFH). Study Design Two-part (1 year double-blind inclisiran versus…
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ORION-16
Trial Study to Evaluate Efficacy and Safety of Inclisiran in Adolescents With Heterozygous Familial Hypercholesterolemia (ORION-16). ClinicalTrials.gov Identifier: NCT04652726 Aim To investigate the efficacy, safety, and tolerability of inclisiran in adolescents diagnosed with heterozygous familial hypercholesterolaemia (HeFH). Study Design Two-part (1 year double-blind inclisiran versus…
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SPIRE trials: Bococizumab was insufficiently humanized for long-term use
The development of bococizumab, the third of the PCSK9 monoclonal antibodies, was discontinued by Pfizer in early November (1). Insights from a late breaker trial presentation provide some answers why this might be the case. SPIRE programme: lipid lowering trials The SPIRE program included 6…
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SPIRE trials: Bococizumab met primary endpoint in 4 trials
Following on the tails of the first two licensed PCSK9 monoclonal antibodies, there are encouraging early results from Phase III trials with the third PCSK9 monoclonal antibody bococizumab. Topline results from studies in patients with heterozygous familial hypercholesterolemia (SPIRE-FH), high cardiovascular risk (SPIRE-HR), or elevated…
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Phase I study
Trial Phase I trial, reformulated ALN-PCS Aim To investigate the safety, tolerability and LDL cholesterol lowering of ALN-PCSsc (subcutaneous injection) Study design Part A (single dose): Randomised 3:1, Single blind, Placebo controlled designPart B (multi dose): Randomised 6:2, Single blind, Placebo controlled, On or off…
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SPIRE-2
Trial SPIRE-2: Evaluation of Bococizumab (PF-04950615; RN316) in Reducing the Occurrence of Major Cardiovascular Events in High Risk Subjects ClinicalTrials.gov Identifier: NCT01975389 Aim To evaluate whether bococizumab compared to placebo reduces the occurrrence of major cardiovascular events in high risk subjects who are receiving background…
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SPIRE-1
Cardiovascular outcomes studies with bococizumab Trial SPIRE-1: Evaluation of Bococizumab (PF-04950615;RN316) in Reducing the Occurrence of Major Cardiovascular Events in High Risk Subjects ClinicalTrials.gov Identifier: NCT01975376 Aim To evaluate whether bococizumab compared to placebo, reduces the occurrence of major cardiovascular events, including cardiovascular death, myocardial…
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SPIRE-LDL
Trial SPIRE-LDL: Randomized Clinical Trial of Bococizumab (PF-04950615; RN316) in Subjects With Hyperlipidemia or Mixed Dyslipidemia at Risk of Cardiovascular Events ClinicalTrials.gov Identifier: NCT01968967 Aim To assess the efficacy, safety and tolerability of bococizumab to lower LDL-C Study design Multicentre, double-blind, randomized, placebo-controlled, parallel-group study…
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SPIRE-LL
Trial SPIRE-LL: Randomized Clinical Trial of Bococizumab (PF-04950615; RN316) in Subjects With Primary Hyperlipidemia or Mixed Dyslipidemia At Risk Of Cardiovascular Events ClinicalTrials.gov Identifier: NCT02100514 Aim To assess the efficacy, safety and tolerability of bococizumab in subjects with hyperlipidemia on background statin therapy Study design…
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SPIRE-FH
Trial SPIRE-FH: A 52 Week Study To Assess The Use Of Bococizumab (PF-04950615; RN316) In Subjects With Heterozygous Familial Hypercholesterolemia ClinicalTrials.gov Identifier: NCT01968980 Aim To assess the efficacy, safety and tolerability of bococizumab in subjects with heterozygous familial hypercholesterolemia Study design Multicentre double-blind, randomized, placebo-controlled,…
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SPIRE-HR
Trial SPIRE-HR: Randomized Clinical Trial Of Bococizumab (PF-04950615; RN316) In Subjects with Hyperlipidemia Or Mixed Dyslipidemia At Risk Of Cardiovascular Events ClinicalTrials.gov Identifier: NCT01968954 Aim To assess the efficacy, safety and tolerability of Pf-04950615 In subjects with primary hyperlipidemia or mixed dyslipidemia at risk of…
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SPIRE-AI
Trial SPIRE-AI: Efficacy, Safety, Tolerability And Actual Use Study Of Bococizumab And An Autoinjector (Pre-Filled Pen) In Subjects With Hyperlipidemia Or Dyslipidemia ClinicalTrials.gov Identifier: NCT02458287 Aim To assess the efficacy, safety, tolerability and subcutaneous administration of bococizumab 150mg and 75mg with a pre-filled pen Study…
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SPIRE-SI
Trial SPIRE-SI: Randomized Clinical Trial of Bococizumab (PF-04950615; RN316) in Subjects Who Are Intolerant to Statins ClinicalTrials.gov Identifier: NCT02135029 Aim To demonstrate a superior lipid lowering effect of bococizumab compared to placebo in subjects who are statin intolerant Study design Multicentre, double-blinded, active- and placebo-controlled…
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